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Publication numberUS4967773 A
Publication typeGrant
Application numberUS 07/066,494
Publication dateNov 6, 1990
Filing dateJun 26, 1987
Priority dateJun 26, 1986
Fee statusLapsed
Also published asDE3774341D1, EP0251642A1, EP0251642B1
Publication number066494, 07066494, US 4967773 A, US 4967773A, US-A-4967773, US4967773 A, US4967773A
InventorsAlec S. W. Shaw
Original AssigneeShaw Alec S W
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Nicotine containing lozenge
US 4967773 A
Abstract
There is disclosed a lozenge formed by compression of at least two mixed components, one of said components including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein such that there is no direct contact between the nictone and the lactose whilst together in the lozenge.
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Claims(10)
I claim:
1. A lozenge formed by compression of at least two mixed components, one of said components including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein such that there is no direct contact between the nicotine and the lactose whilst together in the lozenge.
2. A lozenge according to claim 1 wherein said first component comprises lactose or a lactose containing substance and a binder.
3. A lozenge according to claim 2 having between 5% and 30% by weight of said binder therein.
4. A lozenge according to claim 2 wherein said binder comprises acacia powder.
5. A lozenge according to any preceding claim wherein said first component includes one or more of the following ingredients: cocoa, liquorice, aniseed, peppermint, icing sugar.
6. A lozenge according to any preceding claim wherein the first component is wet granulated and dried.
7. A lozenge according to any preceding claim wherein the carrier of said second component comprises a synthetic silica formulation.
8. A lozenge according to any preceding claim having between 0.1 and 8 mg of nicotine therein.
9. A lozenge according to any preceding claim wherein a lubricant is added to the two components before compression thereof.
10. A lozenge formed by compression of at least two mixed components, one of said components including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein, and additionally containing a lubricant comprising magnesium stearate to facilitate said compression, said two mixed components being such that there is no direct contact between the nicotine and the lactose while together in the lozenge.
Description

This invention concerns a nicotine containing lozenge.

Such lozenges are used by smokers either as a substitute for cigarettes or the like in no-smoking areas or as an aid in giving up the smoking habit.

One problem with such lozenges is the nausea and discomfort that can follow the ingestion of nicotine or nicotine containing substances.

It is well known that lactose is an effective antidote to nicotine poisoning and the unpleasant symptoms aforesaid.

Hitherto it has not, however, been possible to incorporate lactose or a lactose containing substance into a nicotine containing lozenge since contact between the nicotine and the lactose has caused a reaction destroying the effect of the nicotine

It is an object of the present invention to provide a lozenge containing both nicotine and lactose and which overcomes the problem aforesaid.

According to the present invention there is provided a lozenge formed by compression of at least two mixed components, one of said components including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein such that there is no direct contact between the nicotine and the lactose whilst together in the lozenge.

The component including lactose or a lactose containing substance may be granulated and dried.

The invention will be further apparent from the following description which concerns, by way of example, only a number of nicotine containing lozenges embodying same.

The lozenges are produced by compression of a mixture of at least two components using conventional tablet forming machinery.

The first component is prepared from a mixture of lactose or lactose containing substance and a suitable binder.

A typical formulation for the first component might comprise:

______________________________________Acacia Powder   1000 gmsLactose         2900 gms______________________________________

together with desired flavouring and colouring agents, for example:

______________________________________Liquorice              1000   gmsCocoa                  500    gmsAniseed Flavouring     37     gmsPeppermint Flavouring  20     gms______________________________________

If desired, up to 10 kgms of Icing Sugar may be incorporated in the formulation.

The lactose may be replaced by skimmed milk powder, a whey or other milk product.

The acacia powder may be replaced by Avicel micro-cellulose manufactured by FMC Corporation, USA or a similar gum material.

Any of these formulations may include other additives such as sodium bicarbonate, sodium carbonate or potassium hydroxide or aluminium hydroxide for example.

Water is added to the formulation which is then wet granulated and dried in preparation for addition to the second component.

The second component comprises an inert carrier in which nicotine oil or a nicotine derivative which might conveniently be dissolved in alcohol is absorbed.

One suitable carrier comprises a synthetic silica formulation marketed under the trade name Syloid by W R Grace Limited of North Dale House, North Circular Road, London. This has an average particle size in the range of from 1.5-14 microns and can absorb between 75 and 320% of its own weight of oil.

The carrier and nicotine oil and any other desired additives such as other oils for flavour are gently mixed to cause the oil to be fully absorbed.

The two components are then gently mixed together with a lubricant such as magnesium stearate and compressed into small lozenges.

Each lozenge having a weight of 70-500 mg will typically contain between 0.1 and 8 mg of nicotine preferably in the range of 0.5-2 mg.

Generally, the acacia or Avicel will constitute between 5% and 30% by weight and preferably in the region of 13% by weight of the total dry weight of the finished lozenge.

It will be appreciated that it is not intended to limit the invention to the above example only, many variations, such as might readily occur to one skilled in the art, being possible, without departing from the scope thereof as defined by the appended claims.

For example, the wet granulation and drying steps in the preparation of the first component may be eliminated if pre-granulated lactose is used.

Patent Citations
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Non-Patent Citations
Reference
1 *The Extra Pharmacopoeia Martindale, 28th Edition 1982, pp. 1732 1733 Re: Nicotine .
2The Extra Pharmacopoeia Martindale, 28th Edition 1982, pp. 1732-1733 Re: "Nicotine".
3The Pharmaceutical Codex, 11th Edition 1979, p. 501 Re: "Lozenges" and pp. 906-908.
4 *The Pharmaceutical Codex, 11th Edition 1979, p. 501 Re: Lozenges and pp. 906 908.
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US5512306 *Nov 7, 1994Apr 30, 1996Pharmica AbSmoking substitute
US5525351 *Dec 20, 1993Jun 11, 1996Dam; AndersNicotine containing stimulant unit
US5543424 *Oct 19, 1995Aug 6, 1996Pharmacia AbSmoking substitute
US6183775May 6, 1997Feb 6, 2001Novartis Consumer Health S.A.Buccal delivery system
US6344222Sep 2, 1999Feb 5, 2002Jsr LlcNicotine, hydrophilic and hydrophobic polymer, buffer; time-relese agents
US6358060Sep 3, 1998Mar 19, 2002Jsr LlcTwo-stage transmucosal medicine delivery system for symptom relief
US6668839May 1, 2001Dec 30, 2003Jonnie R. WilliamsSmokeless tobacco product
US6834654Apr 30, 2002Dec 28, 2004Regent Court Technologies, LlcSmokeless tobacco product
US7767698Jun 2, 2003Aug 3, 2010Mcneil AbA pharmaceutical liquid comprising nicotine, a buffer or pH controller; spraying an aerosol into the mouth for deliverying into the lungs, for treating tobacco addiction; new pharmaceutical formulation
US8093262May 13, 2010Jan 10, 2012President And Fellows Of Harvard CollegeUse of huperzine for disorders
US8193212May 23, 2006Jun 5, 2012President And Fellows Of Harvard CollegeUse of huperzine for neuropathic pain
US8323683May 18, 2005Dec 4, 2012Mcneil-Ppc, Inc.Flavoring of drug-containing chewing gums
US8469036Nov 5, 2004Jun 25, 2013U.S. Smokeless Tobacco Company LlcTobacco compositions
US8470366Feb 17, 2011Jun 25, 2013Jatin ThakkarNicotine containing soft gelatin pastilles
US8501164Apr 30, 2009Aug 6, 2013GlaxoSmithKline, LLCNicotine lozenge compositions
US8627828Jan 31, 2006Jan 14, 2014U.S. Smokeless Tobacco Company LlcTobacco compositions
US8636011Dec 29, 2008Jan 28, 2014U.S. Smokeless Tobacco Company LlcTobacco compositions
US8642016Jul 20, 2007Feb 4, 2014Jsrnti, LlcMedicinal delivery system, and related methods
US8642627Jun 18, 2010Feb 4, 2014Mcneil AbFormulation and use thereof
US8658200Oct 28, 2012Feb 25, 2014Mcneil-Ppc, Inc.Flavoring of drug-containing chewing gums
US8741348Dec 19, 2003Jun 3, 2014Niconovum AbPhysically and chemically stable nicotine-containing particulate material
EP1803444A2Dec 19, 2003Jul 4, 2007NicoNovum ABA method for the preparation of a nicotine-containing particulate material with a crystalline cellulose (in particular MCC)
EP2233134A1Mar 26, 2010Sep 29, 2010McNeil ABMulti-portion intra-oral dosage form with organoleptic properties
EP2324837A1Dec 21, 2007May 25, 2011Trustees Of Tufts CollegeSynthetic lipophilic inositol glycans for treatment of glucose-metabolism disorders
WO2009134947A1 *Apr 30, 2009Nov 5, 2009Smithkline Beecham CorporationNicotine lozenge compositions
WO2011081628A1Dec 30, 2009Jul 7, 2011Novartis AgMelt extruded nicotine thin strips
WO2013043835A2Sep 20, 2012Mar 28, 2013R. J. Reynolds Tobacco CompanyTranslucent smokeless tobacco product
WO2013158643A2Apr 16, 2013Oct 24, 2013R. J. Reynolds Tobacco CompanyRemelted ingestible products
Classifications
U.S. Classification131/359, 424/747, 424/757, 514/343, 131/369
International ClassificationA61K9/20, A23G3/00, A23G3/48, A61K9/00, A61K31/465, A61K36/534, A23G3/36
Cooperative ClassificationA23G3/48, A61K9/0056, A23G3/36, A61K31/465, A23G3/368
European ClassificationA23G3/48, A23G3/36M4, A61K31/465, A61K9/00M18B, A23G3/36
Legal Events
DateCodeEventDescription
Jan 17, 1995FPExpired due to failure to pay maintenance fee
Effective date: 19941104
Nov 6, 1994LAPSLapse for failure to pay maintenance fees
Jun 14, 1994REMIMaintenance fee reminder mailed
Jul 9, 1990ASAssignment
Owner name: CHARWELL CONSUMER PRODUCTS LIMITED, CHANNEL ISLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:SHAW, ALEC STANLEY WALTER;REEL/FRAME:005397/0330
Effective date: 19900427